Primary Device ID | 10814639026686 |
NIH Device Record Key | 3000884c-9a77-4f5d-97f0-27172d962014 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | UNIFY Chromic Surgical Sutures |
Version Model Number | M-C518R19 |
Company DUNS | 017524666 |
Company Name | APPLIED DENTAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00814639026689 [Primary] |
GS1 | 10814639026686 [Package] Contains: 00814639026689 Package: box [12 Units] In Commercial Distribution |
GS1 | 20814639026683 [Package] Package: Case [50 Units] In Commercial Distribution |
GAL | Suture, Absorbable, Natural |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-06-27 |
Device Publish Date | 2025-06-19 |
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10814639021261 | UNIFY Chromic Surgical Sutures, LG 2-0, 26mm 1/2 Cir Taper point, 27" |
10814639021254 | UNIFY Chromic Surgical Sutures, LG 2-0, 24mm 3/8 Circle Rev Cut, 27" |
10814639026686 | UNIFY Chromic Surgical Sutures, Med 5-0, 19mm 3/8 Circle Rev Cut, 18" |